The following data is part of a premarket notification filed by Customed, Inc. with the FDA for Fanfold Drape 41 X 57 Product No. 900-633, Recorder No. 0633.
| Device ID | K974647 |
| 510k Number | K974647 |
| Device Name: | FANFOLD DRAPE 41 X 57 PRODUCT NO. 900-633, RECORDER NO. 0633 |
| Classification | Drape, Surgical |
| Applicant | CUSTOMED, INC. CALLE IGUALDAD #7 Fajardo, PR 00738 |
| Contact | Gladynell Rodriguez |
| Correspondent | Gladynell Rodriguez CUSTOMED, INC. CALLE IGUALDAD #7 Fajardo, PR 00738 |
| Product Code | KKX |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-12-12 |
| Decision Date | 1998-01-05 |